Adverse events to compounding drugs in Brazil: Assessment of pharmaceutical knowledge and practice

Abstract

The notification of adverse events (AE) caused by compounded medicines in Brazil represents 0,2% of the total number of notifications, denoting a high incidence of underreporting. The conduct of compounding pharmacists towards pharmacovigilance and the reporting of these events is an important element in promoting the safe use of this category of medicines. To evaluate the knowledge and practice of pharmacists working in magistral pharmacies about the reporting of AE in Brazil, a cross-sectional study was conducted using a validated remote questionnaire available on the website of the National Association of Magistral Pharmacists (ANFARMAG). The participants were pharmacists of a wide range of ages and years of experience, most of whom were female and had a postgraduate degree in Pharmaceutical Sciences. The highest percentage of correct answers was on knowledge of pharmacovigilance, but most of the answers on conduct and practices were inadequate. Reporting the suspicion of any AE was recognized as important, however, a percentage of pharmacists stated that report serious AE whose causality has already been established. The majority do not notify the pharmacovigilance system and only record it internally in the pharmacy's incident book. This situation obscures or omits the real safety profile of these products.